Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cancer combo trial pulled before it even started

NCT ID NCT04031872

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study aimed to test a combination of two drugs—LY3200882 and capecitabine—in people with advanced colorectal cancer that had stopped responding to chemotherapy. The goal was to see if the combination could re-sensitize tumors to treatment. However, the trial was withdrawn before enrolling any patients, so no data were collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY3200882 (a TGF-beta inhibitor) combined with capecitabine (a chemotherapy drug)
What this could lead to
If it had worked, this could have pointed toward a new treatment option for people with chemotherapy-resistant colorectal cancer.
What could go wrong
The trial was withdrawn before enrolling any participants, so no results are available. It is unclear if the combination would have been safe or effective.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Started

Jan 2020

Finished

Jan 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histological or cytological proof of CRC; 2. Disease progression or relapse upon at least one line of treatment for advanced CRC with fluoropyrimidine containing chemotherapy as single agent or in combination (combinations with oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab are allowed); 3. Written documentation of activated TGF-β signature-like gene signature, as determined by the validated assay of Agendia; 4. Age ≥ 18 years; 5. Able and willing to give written informed consent; 6. WHO performance status of ≤ 1; 7. LVEF ≥ 55%; 8. Able and willing to undergo blood sampling for PK and PD analysis; 9. Able and willing to undergo tumor biopsies before start, during treatment and at the end of treatment 10. Life expectancy ≥ 3 months allowing adequate follow up of toxicity evaluation and anti-tumor activity; 11. Evaluable disease according to RECIST 1.1 criteria (measurable disease for the phase II part; evaluable disease is sufficient for the phase I part); 12. Minimal acceptable safety laboratory values 1. ANC of ≥ 1.5 x 109 /L 2. Platelet count of ≥ 100 x 109 /L 3. Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALAT and ASAT ≤ 3.0 x ULN, or ALAT and ASAT ≤ 5 x ULN in patients with liver metastases 4. Renal function as defined by serum creatinine ≤1.5 x ULN 5. Creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula or MDRD); 13. Negative pregnancy test (urine or serum) for female patients with childbearing potential. Exclusion Criteria: 1. Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment; 2. Known or suspected dihydropirimidine dehydrogenase deficit (Mutant for DPD\*2A genotype, 1236 GA genotype, 1679TG genotype and 2846A\>T genotype); 3. Symptomatic or untreated leptomeningeal disease; 4. Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enrol. Brain metastasis must be stable with verification by imaging (e.g. brain MRI or CT (\<21 days before start of treatment) completed at screening demonstrating no current evidence of progressive brain metastases). Patients are not permitted to receive enzyme inducing anti-epileptic drugs or corticosteroids; 5. History of cardiac disease, including myocardial infarction within 6 months before study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension, major cardiac abnormalities, a predisposition for developing aneurysms including family history of aneurysms, Marfan syndrome, bicuspid aortic valve, or evidence of damage to the large vessels of the heart. 6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LY3200882 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection); 7. Woman who are pregnant or breast feeding; 8. Radio- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed; 9. Patients who have undergone any major surgery within the last 2 weeks prior to starting study drug or who would not have fully recovered from previous surgery; 10. Active infection requiring systemic antibiotics or uncontrolled infectious disease; 11. Patients with a known history of hepatitis B or C or known Human Immunodeficiency Virus HIV-1 or HIV-2 type patients; 12. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for the study; 13. Known hypersensitivity to one of the study drugs or excipients. 14. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \<1% per year (when used consistently and correctly) during the treatment period and for at least 90 days after the last dose of LY3200882 and/or capecitabine. More information is available in section 5.2.4. 15. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined in section 5.2.4.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Colorectal cancer metastatic are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

More trials for these conditions

Other studies related to the condition(s) this trial covers.